Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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  • Thumbnail showing gene therapy delivery challenge with disrupted DNA pathway

    Gene Therapy Delivery Challenges Explained

    In this episode of MedDevice by Design, Ariana Wilson and Mark Drlik explore what sits beneath that progress, focusing on how these therapies are delivered and why delivery remains one of the hardest problems to solve.

  • Smartwatch displaying heart rate and ECG-style waveform, illustrating the difference between wellness devices and medical devices in digital health regulation

    Medical vs Wellness Devices: What Really Makes the Difference?

    Ariana Wilson and Mark Drlik break down medical vs wellness devices and explain why two products with identical hardware can fall into completely different regulatory categories.

  • Visual comparison supporting clinical ventilator development and commercial device design.

    Clinical Ventilator Development Explained

    Understanding how clinical ventilator development differs from commercial ventilator design is essential for teams planning early studies.

  • Grocery store aisle with red arrows highlighting items that reveal hidden health data, illustrating how consumer shopping behavior can signal medical information.

    Consumer Health Prediction in Everyday Shopping

    Consumer health prediction shapes more of daily life than most people realize. In this episode of Bio Break, Nick and Nigel explore how retail data can reveal health information without a person ever speaking to a clinician.

  • Nick showing a biofilm conference book while Nigel listens, with overlay text reading FDA Asked For It and a red arrow pointing to the book.

    Biofilm Referencing Lesson

    When reviewing evidence for a medical device, a single citation can shape an entire submission. In this Bio Break episode, Nick shares a biofilm referencing lesson that has stayed with him since the early 2000s.

  • Diagram showing medical device at the center connected to clinicians, patients, and regulatory bodies with text 'Who are we designing for?' highlighting stakeholder mapping in MedTech design.

    Understanding Medical Device Stakeholders

    Every phase of a device’s life cycle involves different people with distinct needs—from clinicians and patients to service technicians and regulatory bodies.

  • Black alarm clock disintegrating into particles beside the bold text ‘Faster launch?’ on a yellow background, symbolizing accelerating medical device development timelines.

    Reducing Device Development Timelines: People, Process, and Tools

    Ariana Wilson and Mark Drlik explore how teams can reduce the device development timeline without compromising quality or compliance.

  • icons representing different medical device classes

    Difference Between Class 1, 2, and 3 Medical Devices

    Understanding medical device classifications is critical for compliance, risk management, and time-to-market success. Whether you’re designing a wearable sensor or a life-sustaining implant, knowing how your device fits into FDA Class 1, 2, or 3 categories is essential.

  • Cover of the free StarFish Medical guide “Drug Delivery Decisions,” featuring a gradient design with wave patterns, offering insights on drug-device combination product strategy.

    Drug Delivery Strategy Guide

    This in-depth drug delivery strategy guide from StarFish Medical explores how to design, develop, and deliver breakthrough drug-device combination products.